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1 Continuing Evolution of U.S. Nuclear Quality Assurance Principles, Practices and Requirements PART II - A Tutorial August 2005 This document is for information only and is not a part of the ASME NQA-I-2004 Standard.

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2 NQA Historical and Tutorial Purposes PART I describes how nuclear quality assurance (NQA) has evolved in the U.S. over 50 years from 1954 as reactions and responses to:  public concerns  government regulations  program needs  experiences  quality failures  external events PART II (this part) is intended to acquaint the next generation of management, technical and quality professionals with NQA):  terms and definitions  paradigm shifts from ineffectual concepts  principles underlying NQA-1 requirements  program lessons

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6 Terms and Definitions Quality: The condition achieved (or existing) when an item, service or process meets or exceeds the users’ requirements or expectations (Source:DOE) Quality assurance : All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. (Source: 10 CFR 50 Appendix B) All those actions that provide confidence that quality is achieved (or exists) (Source:ASME NQA-1)

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8 NQA Paradigm Shift Ineffective Concept Quality is “inspected into” an item. Present NQA-1 Culture Quality is achieved by people possessing the competence, skills, knowledge, experience, training, resources and work ethic and motivation to do the job right.

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9 NQA Paradigm Shift Ineffective Concepts NQA-1 was written by and for QA professionals NQA applied only to safety structures, systems and components NQA program required strict compliance with inflexible requirements and procedures Present NQA-1 Culture NQA-1 is written by and for managers, performers and verifiers. NQA-1 requires a quality management system that applies to safe and reliable operation across the nuclear facility. NQA-1 program applies a sensible graded approach that is both compliance and performance oriented.

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11 NQA Paradigm Shift Ineffective Concept A QAP generates excessive amounts of paper. Present NQA-1 Culture QAP documentation is readily available to provide sufficient objective evidence and a defensible record that NQA requirements and commitments have been met.

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12 NQA Program Lesson “No quality assurance program is self- executing. Thus, irrespective of how comprehensive it may appear on paper, the program will be essentially without value unless it is timely, improved and properly implemented.” ( Source: ASLB at Consumer Power Midland Station public licensing hearings, March 1973)

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13 NQA Program Lesson “Top-down management commitment to quality is a primary project objective. Top management must understand the magnitude, complexity and difficulties in designing and constructing nuclear power plants compared to conventional steam plants, and the importance of applying exacting engineering and quality standards. Prior nuclear facility design and construction experience of key project personnel is essential.” ( Source NRC NUREG-1055) “Improving Quality and the Assurance of Quality in the Design and Construction of Nuclear Power Plants”

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15 NQA Program Lesson The QAP is implemented as an integral part of a comprehensive management system. The QAP supports prompt detection, communication and correction of quality problems in design, effective management system oversight of the design process, and the ability to control plant configuration and manage change. ( Source: NRC NUREG-1055, as modified)

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18 Underlying NQA-1 Principles NQA-1 BR 3 Design Control BR 4 & 7 Procurement BR 5 Instructions, procedures and drawings Items are designed and changes controlled using sound engineering practices, analyses and configuration management Designs are analyzed and verified Items and services are purchased, accepted and controlled to specified requirements Work processes are planned and controlled Activities are performed in accordance with prescribed documentation Management ensures the right people have the right information at the right time

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19 Underlying NQA-1 Principles NQA-1 BR 6 & 17 Documents and records BR 8 & 13 Item identification and control BR 9 Process control  Quality documents and records are developed, identified and controlled in accordance with specified requirements  Items are identified and controlled during shipping, handling, installation or use to assure their quality and prevent damage, loss or deterioration  Special processes for achieving quality are performed under controlled conditions to specified requirements  Use of correct materials, tools and processes and control changes is assured